From: Jean-Claude Pommet [jcpommet@videotron.ca]
Sent: Saturday, March 24, 2001 9:49 AM
To: fdadockets@oc.fda.gov
Subject: "Docket 00N-1396 & Docket 00D-1598"
FDA,
To whom it may concerns,
GENETICALLY ENGINEERED PRODUCTS MUST BE LABELED AND TESTED FOR SAFETY!
* The FDA must require mandatory pre-market comprehensive environmental
review. Unlike conventional pollutants, where a given amount of
pollutant causes a limited amount of damage, a small number of mutant
genes could have a population explosion and reproduce forever, causing
unlimited and irreparable damage.
* The FDA must require mandatory pre-market long-term health testing.
GE products could be toxic, cause allergic responses, have lower
nutritional value, and compromise immune responses in consumers.
* The FDA must require mandatory labeling of GE products. Without
mandatory labeling, neither consumers nor health professionals will know
if an allergic or toxic reaction was the result of a genetically
engineered food. Consumers would be deprived of the critical knowledge
needed to hold food producers liable should any of these novel
products be hazardous.
* The FDA must end its cozy relationship with the industries it purports
to be regulating. People have been allowed to work for a biotech
company, then work for the FDA writing the regulatory rules on that
company's product, then go back to
working for the company. Ninety-two percent of FDA advisory committee
meetings had at least one conflict of interest.
------------------------------------------------------------------------------------
The following was prepared by Consumers for Education about Genetic
Engineering.
13 Myths About Genetic Engineering
Myth No. 1 - Genetic engineering (GE) is not new. It is just the same
as speeded-up selective breeding.
FACT: Genetic engineering (GE) and conventional breeding are worlds
apart. Breeding does not manipulate genes; it involves crossing of
selected parents of the same or closely related species. In contrast,
GE involves extracting selected genes from one organism (e.g. animals,
plants, insects, bacteria) and/or viruses, or synthesising copies, and
artificially inserting them into another completely different organism
(eg. food crops). GE usually employs virus genes to smuggle in and
promote the inserted genes, and antibiotic resistance genes to act as
markers. All these inserted genes are present in every cell of the
plant.
Myth No. 2 - Genetic engineering is precise.
FACT: The function of only a small proportion of the DNA in a higher
organism is known. Modern genetics has shown that genes do not operate
in isolation. Rather they interact in a complicated way, changing their
behaviour in response to influences from other genes. Although a gene
can be cut out precisely from the DNA of an organism, its insertion into
the DNA of another organism is entirely random. This results in the
disruption of the order of the genes on the chromosome and may result in
random and
unexpected changes in the functioning of the cells.
Richard Lewontin, Professor of Genetics at Harvard University, has said
of GE: 'We have such a miserably poor understanding of how the organism
develops from its DNA that I would be surprised if we don't get one rude
shock after another.' Myth No. 3 - GE foods vary from non-GE foods only
in the characteristic that has been modified.
FACT: The random insertion of foreign genes into the genetic material
may cause unexpected changes in the functioning of other genes. Existing
molecules may be manufactured in incorrect quantities, at the wrong
times, or new molecules may be produced. GE foods and food products may
therefore contain unexpected toxins or allergenic molecules that could
harm our health or that of our offspring.
Myth No.4 - GE food is extensively tested and the GE food at present on
our supermarket shelves is perfectly safe to eat.
FACT: No GE food testing is done in America. We rely almost entirely
on the testing carried out by the GE biotechnology companies that have
spent billions of dollars developing the food and intend to make a
profit selling it to us. There are serious doubts about the adequacy of
the testing and the validity of the conclusions drawn from the results.
Independent long-term testing is required before we can be sure that GE
food is safe to eat. Another health concern is the possible
acceleration of the development of bacterial resistance to antibiotics
due to the use of antibiotic resistance genes in the production of GE
foods.
Myth No. 5 - Genetically engineered food has improved nutritional
value.
FACT: No GE food produced to date has been shown to be more nutritious
than non-GE food. Most GE crops are only designed to be resistant to
specific herbicides, to produce their own insecticides or to have an
increased shelf life.
Myth No.6 - One can always choose not to eat GE food.
FACT: At present most foods on American supermarket shelves containing
GE ingredients are not labelled, so there is no way of knowing whether
we are eating them. GE products are likely to be found in foods
containing the following ingredients:
Soya flour and oil (in many common foods including breads, sausages,
etc.)
Lecithin (in chocolate, ice cream etc.) Canola oil Corn (maize)
extracts.
Myth No. 7 - Farmers will benefit from growing GE crops.
FACT: Seeds of genetically engineered crops are more expensive than
those of conventional crops. Farmers in the UK and USA report that
yields are generally no better, the crops are less reliable and overall
have not improved profitability. Non-GE crops now receive a premium and
as more countries reject GE foods, the pportunities to sell GE produce
overseas are diminishing. Because of risks associated with GE crops
insurance companies in the USA and UK are now reluctant to insure them.
Farmers growing GE crops have to sign binding contracts with the
biotechnology producers. These commit them to using only the herbicides
produced by that company and prohibit them from the traditional practice
of saving seed for the next season. Most third world farmers certainly
will not benefit.
Myth No.8 - GE crops will reduce the use of herbicides and pesticides.
FACT: Crops engineered to be resistant to specific herbicides may
encourage more liberal use of those herbicides. This has been
anticipated by one manufacturer, who has applied to ANZFA (Australia New
Zealand Food Authority) to have the allowable residue of the herbicide
glyphosate (Roundup=AE) in foods sold in New Zealand increased by 200
times. In areas of the USA where crops engineered to produce their own
insecticide are grown, pesticide use has not decreased.
Myth No. 9 - There is no evidence that GE crops are harmful to the
environment.
FACT: Insects, birds and the wind carry genetically altered pollen and
seeds into neighbouring fields and far beyond. Cross-pollination occurs
between GE crops and non-GE crops and their wild relatives. In this way
resistance to weed killer, for example, might be transmitted to weeds
making them more difficult to control. There is evidence that crops
engineered to produce their own insecticide can kill beneficial insects.
Myth No. 10 - GE crops will save the world from famine.
FACT: A major cause of famine is the unequal global distribution of
food. Food mountains exist in much of the western world and food is
regularly dumped. Poor people have limited ability to buy either GE or
non-GE food. There is no evidence that GE crops produce higher yields
than conventional crops or that GE products will be cheaper.
Myth No. 11 - You can trust the scientists that GE food is good for you
and the world.
FACT: The money for scientific research on GE here and overseas comes
from either the biotechnology companies or the government. Both are
committed to the promises of biotechnology. This means that even when
scientists have concerns about the safety or commercial application of
the technology, it is often hard for them to risk their careers by being
openly critical.
One respected scientist in the UK who spoke up about his experimental
results showing damaging effects of feeding rats on a type of
genetically engineered potato was immediately fired from his job.
Myth No. 12 - You can't stop progress.
FACT: No of course we can't; and why would we want to? Progress
implies change for the better. Change for the worse is regression. We
must be sure that GE products have benefits for the consumer and are
safe if they are to be introduced into our foods. We must not commit
ourselves to a dubious technology that cannot be reversed.
Myth No. 13 - There are more important things to worry about than GE
foods.
FACT: Many scientists don't think so. For example Joseph Rotblat, the
British physicist who won a 1995 Nobel Prize says:
"My worry is that other advances in science may result in other means of
mass destruction, maybe more readily available even than nuclear
weapons. Genetic engineering is quite a possible area, because of these
dreadful developments that are taking place there."
-----------------------------------------------------------------------------------
* Lack of Testing
Genetically engineered (GE) foods are being rushed to market without
long-term testing. Dr. Ann Clark, Associate Professor of Crop Science at
the University of Guelph, looked at the research on all 42 approved
biotech foods in Canada. She found that 70% of these crops were approved
without laboratory tests for toxicity. None of the crops were tested for
allergenicity.
Even for the 30% studied for toxicity, the tests were quite limited. For
instance potatoes and corn were engineered to contain a toxin to kill
insect pests. These foods are already on the market though no one knows
the long-term effects on animals or on humans who eat the "toxin
enriched" crops.
* Combining Genes
GE foods combine genes from widely different species. Inserted foreign
genes can unpredictably affect the functioning of host genes. Also,
since these combinations of genes have never been part of the human
diet, unexpected allergies and toxicity are major concerns. But since
these foods are not labelled, it is almost impossible to track any
damaging effects.
* Toxic Effects
Already, one genetically engineered soy, developed by Pioneer Hybrid,
was allergenic, and could have killed people with life-threatening
allergies if it wasn't, by chance, caught and kept off the market. Since
GE soy came on the market, soy allergies have risen 50%. In 1989, 37
people died and thousands were permanently damaged after ingesting a
genetically engineered food supplement, GE tryptophan. Beneficial
insects, such as monarch butterflies and ladybugs, have also died after
eating GE crops.
Because scientists are creating genetic changes overnight that might in
nature take thousands of years, unexpected effects are no wonder. The
potential for damage to human health or to the environment is unknown.
The British Medical Association, representing 115,000 physicians, calls
for a moratorium on all GE crops until more research is done.
* Who Needs It?
Biotech is not needed to feed the world. There already is enough food to
feed the entire globe, if the food were evenly distributed. Studies by
the US Department of Agriculture (USDA) show that biotech crops produce
on average 7% less yield than conventional crops.
In other unexpected effects, biotech cotton in the USA fell off plants
prematurely, creating millions of dollars of damage. In another case, GE
soy burst open in hot weather, because of increased lignin content.
Cross-pollination with biotech crops (genetic pollution) has damaged
organic crops and also produced superweeds, which are immune to
herbicides.
Insects exposed to biotech crops produced superbugs, insect pests immune
to synthetic chemicals and natural pesticides, and which damage both
organic and conventional crops.
* Pesticide Promoters?
Contrary to industry hype, genetic engineering has not produced any
nutritious wonderfoods. The majority of approved GE foods are herbicide
resistant (HR). This allows more use of herbicides to kill weeds without
harming crops. The same companies that makes the HR crops make the
herbicides, and force farmers to use only their herbicides with their
crops, or face fines.
Is the main purpose of GE crops to promote herbicide sales? USDA studies
show that farmers growing HR crops use up to 2-5 times as much
herbicide. Also, as GE crops are patented, biotech companies receive
large royalties from farmers growing the crops. Farmers are also
disallowed from saving seeds from one season to the next.
* Scientists Silenced
Government documents show that GE foods were approved in the USA, even
though many scientists at the US FDA (Food and Drug Administration)
questioned their safety. Two hundred scientists at Health Canada sent a
letter to the Minister of Health saying they are concerned that unsafe
products are rushed to market.
The scientists referred not only to GE foods, but also to antibiotics
and hormones administered to food-producing animals. They stated they
are pressured to approve products of questionable safety, and that even
when they did not recommend approval, products were approved.
* Deregulation
Built into Canada's Food and Drugs Act is the precautionary principle,
which asserts that products should not be approved for sale until proven
safe. However, due to industry pressure, products are allowed on the
market without adequate testing, and then only removed if there is
sufficient evidence of harm (enough "dead bodies").
Deregulation has created several calamities, including Canada's tainted
blood mega-disaster, in which 60,000 people received infected blood that
was not properly tested. Deregulation in Europe allowed cows to be fed
sheep offal, which caused mad cow disease.
* Conclusion
Have we learned our lesson, or are we going to blindly trust industry
and continue to allow genetically engineered on the market without
long-term testing?
--
Jean-Claude Pommet, Bacc./Sc.
University of Ottawa, Canada